Determining the Prevalence of Primary and Secondary Central Line Associated Blood Stream Infection (CLABSI) at the Tertiary Care Hospital

NCT06458231 | Recruiting DMC

• 1 other identifier: Micro
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

Brief Summary

• Review key history and clinical examination findings of cases with CLABSI.
• Microbiological diagnosis and Culture sensitivity tests by automated Bact Alert and Vitek2c systems for CLABSI.
• Determine antibiotic biogram of each organism isolated
• Determine the prevalence of occurrence of Primary or secondary Blood stream infection, causing microorganism, and predisposing factors.

Conditions

Central Line-associated Bloodstream Infection (CLABSI)

Keywords

CLABSI, Primary B.I., Secondary B.I.

Outcome Measures

Primary Outcomes (2)

• • Microbiological diagnosis and Culture sensitivity tests

  • Microbiological diagnosis and Culture sensitivity tests by automated Bact Alert and Vitek2c systems for CLABSI.

  6 months

• Determine antibiotic biogram of each organism isolated

  Determine antibiotic biogram of each organism isolated

  6 months

Secondary Outcomes (1)

• •Determine the prevalence of occurrence of Primary or secondary Blood stream infection

  4 months

Study Arms (4)

No of Positive CLABSI

No of +ve CLABSI in different types of cases,

Device: Blood Catheters

Primary Blood stream infection

Participant with blood stream infection not related to other other infection in the body

Device: Blood Catheters

Secondary Blood stream infection

Blood stream infection occur as a complication to infection in other parts of the body

Device: Blood Catheters

Blood Prevalence of types microorg.

% and Prevalence of different microorg causing Blood stream infection

Interventions

Blood Catheters DEVICE

Central line as a predisposing factor for Blood stream infection

No of Positive CLABSI; Primary Blood stream infection; Secondary Blood stream infection

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Venous blood samples from cases with suspected sepsis, or bacteremia will be incubated with a medium which encourages promotes bacterial growth.

You may qualify if:

• Patients diagnosed with sepsis based on medical history, lab investigations and clinical picture.
• Both sex, and all age-groups.

You may not qualify if:

• Patients diagnosed with sepsis proved by medical history, lab investigations and clinical picture who received non-beta lactam antibiotics for the past 24 hours.
• Samples proved contaminated by microbial flora will be rejected.

Sponsors & Collaborators

• Port Said University: lead

Study Sites (2)

Prof. Refat Sadeq

Port Said, 22223, Egypt

RECRUITING

Faculty of Medicine Portsaid Uni

Port Said, Egypt

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 13, 2024
• Study Start: June 25, 2024
• Primary Completion: September 30, 2024
• Study Completion: May 31, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: after one year

Locations

EG (2)